Stephan Nieuwoudt, Ph.D.

Medical device manufacturing process development and implementation under ISO 13485. Drive V&V, Test Protocol/Method Development, Biological Evaluation, and Regulatory Compliance of medical devices for FDA submission.

Strategic planning and implementation of R&D pipeline towards design transfer. Preclinical surgeon; device design and development engineer; product developer.

Management of product development pipeline - while wearing many other startup hats.

Design and fabrication of functional prototypes for medical research (biotech, devices, diagnostics).

Established laboratory protocols in cellular biology, tissue culture, extracellular matrix production in the study of potential connections between metabolism and cardiac remodeling. Designed and fabricated mid-scale cell perfusion chip with syringe pumps and fraction collector. Received T32 Postdoctoral Fellowship through the Cardiovascular Research Institute.

Clinical and in vitro research on the remediation of type 2 diabetes through exercise. Focus on cellular physiology.

Manage clinical trials and perform molecular biology and cell physiology research studies within the laboratory of John P. Kirwan, PhD, of the Pathobiology Department (Lerner Research Institute). Install and maintain laboratory and clinical research equipment, and perform repairs/improvements where needed using engineering design (CAD, circuit design, prototyping) and basic fabrication techniques.

Worked as a direct assistant to Solomon Afelik, PhD, in the laboratory of Jan Jensen, PhD, studying embryonic pancreas development. Assisted in research activities through maintenance of genetic mouse colonies with PCR analysis. Dissected mice and prepared histological slides for immunohistochemistry. Developed an academic and research foundation in Stem Cell Biology and Regenerative Medicine.

Single-cell whole genome amplification research and product testing.

MeRCIS is at the forefront of robotic heart surgery device development. My responsibility on the project was to install camera modules on the device and write device drivers and software for image and video capture. http://engineering.case.edu/groups/robotics

Thesis dissertation research in Exercise Physiology and Type 2 Diabetes, with a focus in skeletal muscle physiology, hormone secretion (myokines), and exercise as a treatment option for patients with diabetes. My work includes in vitro cell culture models of exercise as well as studying exercise in clinically relevant populations through clinical trails. Mentor: John P. Kirwan (ACSM, PhD), Cleveland Clinic Lerner Research Institute, Department of Pathobiology Dissertation Title: Insights into the Functional Roles of Exercise in Type 2 Diabetes Using In Vitro Models Defense Date: 1 September 2017